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Pharmacogenetics: Opportunities and Challenges for Health Innovation
von: OECD (Ed.)
OECD Paris, 2009
ISBN: 9789264076808, 134 Seiten
Format: PDF, OL
Preis: 28,56 EUR
Table of Contents
6
Foreword
4
Acronyms
8
Executive Summary
10
Introduction to the Policy issues
16
Introduction
17
Reducing risks, balancing benefits
17
The pharmaceutical context
20
The clinical context
22
The regulatory and ethical contexts
23
The framework for the OECD pharmacogenetics and health innovation project
24
Structure of the report
26
Notes
27
The Supporting Infrastructures for Pharmacogenetics
28
What are pharmacogenetics and pharmacogenomics?
30
Technological developments
31
Advancing pharmacogenetics through knowledge networks and open innovation
33
Human genetic research databases: privacy and security issues
34
Target identification and validation
35
Conclusions
40
Notes
41
References
42
Pharmacogenetics and Drug Development
44
Trends in pharmaceutical innovation
45
The pharmaceutical R&D pipeline problem
47
Pharmaceutical industry R&D expenditure: the high cost of clinical trials
51
Reducing the size of clinical trials
53
Conclusions
57
Notes
59
References
60
Business Models for Pharmacogenetics
62
The blockbuster model and pharmacogenetics
63
Challenges and opportunities for the pharmaceutical industry
67
SMEs and the biotechnology sector
69
The device and diagnostics industry
69
Challenges in co-development of drugs and tests
71
Creating and capturing value from pharmacogenetics
73
Conclusions
74
Notes
76
References
77
Physician and Patient Demand for Pharmacogenetics
78
The health-care context
80
The role of pharmacogenetics in evidence-based medicine
81
The role of physicians
84
Physicians and the challenge of integrating information
86
Patient demand
88
The issue of access
89
Health-care systems
92
Education and workforce development
93
Conclusions
94
Notes
95
References
95
Regulatory Authorities and Reimbursement Mechanisms
98
The regulatory authorities
99
Labelling of pharmacogenetic drugs
105
Linking pharmacovigilance with pharmacogenetics
106
The impact of reimbursement systems on pharmacogenetics
107
Evidence-based coverage policies
108
Challenges for capturing the value of pharmacogenetics
114
Using economic evaluation techniques in assessing pharmacogenetics
117
Conclusions
118
Notes
120
References
121
Conclusions
124
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